Vagitrol-V with 10 Ovulos, Fluocinolone, Metronidezol, Nystatin﻿ ﻿

THIS IS A BRAND MEDICATION

OVULES-VMR VAGITROL is recommended for the treatment of vaginitis, cervical infections and parasitic vulvovaginitis etiologies, fungal, infectious, mixed. OVULES-VMR VAGITROL, local acts effectively against vaginitis and cervicitis produced by trichomonas and monilia.

The antifungal activity of VAGITROL-VMR is given by nystatin, known to be effective in diseases caused by Candida albicans, due to its fungistatic and fungicidal action.

The fluocinolone acetonide is a synthetic derivative of cortisol and from the qualitative point of view, share the pharmacokinetics of steroids.

Synthetic glucocorticoids are absorbed from the sites of local application, in magnitude dependent on the application surface area and the time period of administration. Under normal conditions, 90% or more of the steroid is bound reversibly to plasma proteins (albumin and corticosteroid binding globulin).

Cortisol has a plasma half-life of 1.5 hours. Half-life is prolonged corticosteroids if introduces a double bond between positions 1, 2, or a fluorine atom in the molecule.

Glucocorticoids are metabolized by reduction, this occurring in liver and extrahepatic sites, which results in inactive substances sulfate or glucuronide conjugate with water soluble are excreted as such. Such conjugation reactions occur primarily in the liver and to some extent in the kidney. In humans, biliary excretion and fecal no quantitative importance.

Topical steroids are recognized as effective therapeutic agents for the treatment of various skin lesions or mucous membranes.

Fluocinolone is a derivative adrenocortical that has the ability to prevent or suppress the local development of the mechanism of inflammation. Not remove the underlying cause that gives rise to the inflammatory response, but clinical manifestations are suppressed. Signs and symptoms of inflammation, are expressions of the disease process often used by the physician in diagnosing and assessing treatment effectiveness.

Metronidazole has a direct tricomonicida action. Its mechanism of action is on the synthesis and DNA replication of parasitic and bacterial. He is considered the drug of choice in the treatment of genital infections caused by male and female trichomoniasis, with very low incidence of drug resistance and few side effects (local application).

When administered metronidazole topically, vaginally absorption is from 20 to 56% of the dose. Metronidazole is widely distributed through all tissues and body fluids compartments, including vaginal secretions, with a volume of distribution in adults from 0.51 to 1.1 l / kg. The effective concentration of the compound is 8 mg / ml or less for most susceptible bacteria and protozoa. The half-life of the compound is 8 hours and 10% of the drug is bound to plasma proteins.

Metronidazole is metabolized by the liver, leading to the production of 5 metabolites. The liver is responsible for more than 50% of the systemic clearance of the compound. Hydroxylated metabolites, products of oxidation of their side chains, have a biological activity of 30 to 65% and a longer half life than the original salt which also have activity against trichomonas. Most of the administered drug and its metabolites are eliminated through the urinary and fecal incontinence. Approximately 12% of the original substance is eliminated as such through the urine.

The pharmacokinetics of metronidazole is not altered under various pathological conditions such as acute renal failure and chronic, they may need to hemodialysis or intermittent peritoneal dialysis as therapeutic elements, pregnancy or intestinal disease. Renal failure reduces the rate of elimination of its metabolites, however, has not been reported toxicity and does not require adjustment in dose. Liver failure is a decrease in metabolism and elimination of metronidazole, so that under these circumstances, it is recommended to dose adjustment.

Treatment with topical antifungal agents is useful for many superficial mycoses, ie those who are confined to the stratum corneum, or horny layer flaky. These diseases include vaginal candidiasis. The efficacy of topical agents in superficial mycoses, not only depends on the type of lesion and the mechanism of drug action, but also the viscosity of the hydrophobicity and acidity of the formulation.

Nystatin is a macrolide produced by Streptomyces noursei, is useful in yeast as it inhibits the growth of various yeast and fungi pathogenic and nonpathogenic, but not of bacteria. Their antifungal activity is due to lethal produces alterations in the fungal cell membrane. Among the strains most sensitive to it is Candida albicans.

Nystatin is not absorbed through the skin, gastrointestinal tract or vagina.

Contraindications: OVULES VAGITROL-VMR is contraindicated in patients with known hypersensitivity to any component of its formula. Tuberculosis of the mucous membranes, viral diseases such as herpes simplex, varicella, and postvaccinal reaction in pregnancy.

PRECAUTIONS: As with all products containing a topical corticosteroid in its formula, may occur in some cases phenomena of "bounce", so that should be used only in its precise indications.

Should be avoided alcohol during treatment with VAGITROL-VMR, and at least one day after it, because they can present abdominal cramps, nausea, vomiting, headache and flushing.

Use in Pregnancy and Lactation: Not to be used during pregnancy. Egg VAGITROL-VMR is contraindicated in patients with known hypersensitivity to any component of its formula, tuberculosis of the mucous membranes, viral diseases such as herpes simplex, varicella, and postvaccinal reaction in pregnancy.

Adverse Reactions: As with any topical corticosteroid may occur proliferation of non-susceptible organisms, increased infant infection and systemic side effects attributable to the corticosteroid, this is unlikely to occur when using the drug at the recommended dose, as with all drugs, any patient may develop idiosyncratic reactions to components of the formula, plus the side effects are reversible and disappear when treatment is discontinued.

DRUG INTERACTIONS AND OTHER GENDER: At the recommended dose to date unknown.

CHANGES IN THE LABORATORY TEST RESULTS: To date unknown.

PRECAUTIONS IN RELATION TO EFFECTS OF CARCINOGENESIS, MUTAGENESIS, Impairment of Fertility: At the recommended dose to date unknown.

DOSAGE AND ADMINISTRATION: Vaginal.

The recommended dose is one-VMR VAGITROL egg a day for 10 days, must be inserted into the vagina, before bedtime.

Recent studies (Sanchez, S. et al.) Have demonstrated successful treatment with the formulation of VAGITROL-VMR for 5 days in the management of bacterial vaginosis.

It recommends that the doctor tells the patient to become familiar with the instructions included in the box-VA-GITROL VMR OVULES.